Biobank of Lianyungang Maternal and Child Health Hospital, Lianyungang Maternal and Child Health Hospital, Jiangsu, China.
BMC Med Inform Decis Mak. 2023 Oct 16;23(1):222. doi: 10.1186/s12911-023-02318-w.
With the development of big health and big data, cohort research has become a medical research hotspot. As an important repository of human genetic resources, biobanks must adapt to the requirements of large-scale and efficient operation. Thus, biobanks urgently need to design and build a legal, convenient, and efficient information management system.
This study applies the concept of "quality by design" to build a comprehensive biobank information management system based on the analysis of user requirements, legal and regulatory risks, and industry-standard requirements. The system integrates the management of scientific research projects, biological specimens, clinical information, quality control, and multi-dimensional information query and development. After 10 months of its operation, the comprehensive management system was evaluated through statistical analysis of the efficiency of the construction of the pregnancy-birth cohort and the quality of genetic resources.
Since the system's launch, the statistics on cohort construction efficiency show that the enrollment rate of eligible pregnant women has increased, and the rate of missing volunteers has dropped. The time needed to establish a 1000-person cohort (with complete biological samples and clinical information in early, middle, and late pregnancy) was reduced, and the effective tracking rate of the samples was 77.42%. The error rate of the deep cryogenic refrigerator decreased, with a clinical information integrity rate of 96.47%.
The comprehensive biobank information management system constructed with the "quality by design" concept is well suited to meet the requirements of medical research. This study provides a solution for designing a comprehensive information system for medical institutions' biobanks.
随着大健康和大数据的发展，队列研究已成为医学研究热点。生物样本库作为人类遗传资源的重要储存库，必须适应大规模、高效率运作的要求。因此，生物样本库迫切需要设计和构建合法、便捷、高效的信息管理系统。
本研究通过分析用户需求、法律和监管风险以及行业标准要求，应用“质量源于设计”理念，构建了综合生物样本库信息管理系统。该系统集成了科研项目管理、生物样本、临床信息、质量控制以及多维信息查询和开发等功能。经过 10 个月的运行，通过对妊娠-生育队列构建效率和遗传资源质量的统计分析，对综合管理系统进行了评估。
自系统上线以来，队列建设效率统计显示，合格孕妇的入组率提高，志愿者流失率下降。建立 1000 人队列（包括早期、中期和晚期妊娠的完整生物样本和临床信息）所需时间减少，样本有效跟踪率达到 77.42%。深低温冰箱的错误率降低，临床信息完整率达到 96.47%。
应用“质量源于设计”理念构建的综合生物样本库信息管理系统能够很好地满足医学研究的需求。本研究为医疗机构生物样本库综合信息系统的设计提供了一种解决方案。
